达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.701646431654191655141645651653311650940.28
212.781659091661231660160.10
单位质量响应值RSD%判断
12999.5312990.300.06数据可信
供试品溶液-25041501批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1182539-18253990.35089.547.7690.3589.547.76
2182444-18244490.30390.30
3153698-15369876.07576.07
4193174-19317495.61495.61
5183702-18370290.92690.93
6189806-18980693.94793.95
10min1194294-19429496.16896.642.6996.3096.772.70
2194142-19414296.09396.23
3186256-18625692.19092.30
4201403-20140399.68799.83
5196143-19614397.08497.22
6199183-19918398.58898.73
15min1194910-19491096.47396.981.8596.7597.261.86
2194595-19459596.31796.60
3190152-19015294.11894.37
4200513-20051399.24799.54
5196693-19669397.35697.64
6198723-19872398.36198.65
20min1194148-19414896.09697.071.6596.5297.501.66
2195206-19520696.62097.04
3191466-19146694.76995.16
4200585-20058599.28299.72
5197037-19703797.52697.95
6198281-19828198.14298.58
30min1194966-19496696.50197.331.5197.0797.901.52
2195201-19520196.61797.19
3192773-19277395.41695.95
4201083-20108399.529100.12
5197178-19717897.59698.17
6198610-19861098.30598.89
45min1195527-19552796.77997.521.4197.4998.241.42
2195558-19555896.79497.51
3193650-19365095.85096.53
4201384-20138499.678100.42
5197111-19711197.56398.28
6198948-19894898.47299.20
60min1194078-19407896.06197.471.4596.9298.341.45
2195261-19526196.64797.51
3194651-19465196.34597.17
4201332-20133299.652100.54
5197142-19714297.57898.45
6199122-19912298.55899.44
120min1201854-20185499.910100.921.34100.91101.931.35
2201763-20176399.865100.87
3201891-20189199.929100.90
4208507-208507103.203104.24
5203773-203773100.860101.87
6205634-205634101.781102.81
180min1200268-20026899.125100.701.41100.28101.861.41
2202875-202875100.416101.57
3201003-20100399.489100.61
4208186-208186103.044104.24
5203569-203569100.759101.92
6204822-204822101.379102.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1199653-19965398.821100.271.53100.12101.581.53
2200472-20047299.226100.53
3201271-20127199.622100.89
4208209-208209103.056104.40
5202212-202212100.087101.40
6203727-203727100.837102.17
360min1198290-19829098.14699.731.5599.60101.191.55
2200920-20092099.448100.90
3198783-19878398.39099.81
4206923-206923102.419103.92
5201524-20152499.747101.21
6202518-202518100.239101.72
480min1196883-19688397.45098.971.5699.05100.581.56
2198193-19819398.09899.70
3197733-19773397.87199.43
4205374-205374101.653103.31
5200851-20085199.414101.03
6200696-20069699.337100.97
600min1196202-19620297.11398.701.7098.86100.461.70
2197655-19765597.83299.58
3196773-19677397.39599.11
4205347-205347101.639103.45
5200594-20059499.287101.05
6199828-19982898.907100.69
720min1194856-19485696.44797.931.7798.3399.841.77
2196525-19652597.27399.17
3195179-19517996.60698.46
4204392-204392101.166103.13
5197996-19799698.00199.91
6198147-19814798.075100.01
极限1194436-19443696.23997.741.9298.2799.791.91
2195357-19535796.69498.74
3195135-19513596.58598.59
4204657-204657101.298103.41
5197193-19719397.60399.66
6198000-19800098.003100.08
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.991080918108428110839051079916108175610821550.18
29.961074562107657310755680.14
单位质量响应值RSD%判断
108323.82107988.760.22数据可信
供试品溶液-25041501批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140055-400553.7033.957.433.703.957.38
244895-448954.1514.15
340847-408473.7773.78
448180-481804.4554.45
541305-413053.8193.82
640966-409663.7883.79
10min198637-986379.12010.049.509.1310.059.48
2106598-1065989.8569.86
399139-991399.1669.17
4120551-12055111.14611.15
5104776-1047769.6879.69
6122093-12209311.28911.29
15min1144686-14468613.37813.783.1213.4013.803.14
2152576-15257614.10714.13
3143867-14386713.30213.32
4155022-15502214.33314.36
5151644-15164414.02114.04
6146350-14635013.53113.55
20min1181172-18117216.75117.182.7116.7917.222.70
2189651-18965117.53517.58
3181357-18135716.76816.81
4192168-19216817.76817.81
5188969-18896917.47217.51
6181410-18141016.77316.82
30min1241575-24157522.33622.722.0122.4022.782.01
2248539-24853922.98023.05
3241410-24141022.32122.39
4252181-25218123.31623.39
5249374-24937423.05723.12
6241011-24101122.28422.35
45min1315008-31500829.12529.491.8629.2229.591.87
2321100-32110029.68929.79
3313816-31381629.01529.11
4328628-32862830.38530.49
5321526-32152629.72829.83
6313672-31367229.00229.10
60min1371067-37106734.30834.801.5334.4534.941.53
2379724-37972435.10935.26
3374341-37434134.61134.75
4383838-38383835.48935.64
5379899-37989935.12535.27
6369160-36916034.13234.28
120min1561034-56103451.87352.131.2452.0752.331.24
2565522-56552252.28852.49
3562776-56277652.03452.23
4574848-57484853.15053.36
5565343-56534352.27152.47
6553444-55344451.17151.37
180min1681795-68179563.03863.691.6163.3163.961.60
2705230-70523065.20565.48
3685467-68546763.37863.65
4697464-69746464.48764.77
5688381-68838163.64763.92
6674498-67449862.36362.64
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1780978-78097872.20872.351.5672.5772.721.56
2779261-77926172.05072.43
3788746-78874672.92773.29
4801960-80196074.14874.53
5779123-77912372.03772.41
6765168-76516870.74771.11
360min1902652-90265283.45884.181.4783.9384.661.47
2924019-92401985.43485.92
3908700-90870084.01884.49
4927350-92735085.74286.23
5908515-90851584.00084.48
6891830-89183082.45882.93
480min1983704-98370490.95291.431.2591.5592.031.25
2991164-99116491.64292.25
3988769-98876991.42192.02
41006694-100669493.07893.70
5993383-99338391.84792.45
6969287-96928789.61990.22
600min11027923-102792395.04195.771.2795.7896.521.27
21035453-103545395.73796.49
31035863-103586395.77596.51
41056924-105692497.72298.48
51041011-104101196.25197.00
61017857-101785794.11094.84
720min11048567-104856796.94997.631.3697.8398.511.36
21057655-105765597.79098.68
31055070-105507097.55198.43
41080528-108052899.905100.81
51056690-105669097.70198.59
61036832-103683295.86496.74
极限11050163-105016397.09797.681.4098.1298.711.40
21054826-105482697.52898.57
31056401-105640197.67498.70
41082742-1082742100.109101.17
51056935-105693597.72398.76
61037562-103756295.93296.95
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4对照品水分(%)0对照品稀释倍数1250
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.701653131658701650501657021660121655890.25
212.781660431657861659140.11
单位质量响应值RSD%判断
13038.5012982.320.31数据可信
供试品溶液-25041502批-达格列净-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min197070-9707047.98960.2414.8647.9960.2414.85
2114933-11493356.82056.82
3134178-13417866.33466.33
4126367-12636762.47362.47
5110706-11070654.73054.73
6147910-14791073.12373.12
10min1179765-17976588.87190.051.6188.9490.141.62
2178422-17842288.20788.29
3186843-18684392.37192.47
4181951-18195189.95290.05
5183055-18305590.49890.58
6182820-18282090.38290.49
15min1187153-18715392.52492.481.4992.7392.711.50
2183608-18360890.77190.99
3190256-19025694.05894.30
4185116-18511691.51791.75
5185855-18585591.88292.10
6190406-19040694.13294.38
20min1188861-18886193.36892.951.3493.7193.311.35
2184737-18473791.32991.68
3192032-19203294.93695.32
4186096-18609692.00192.37
5187844-18784492.86693.22
6188509-18850993.19493.58
30min1189620-18962093.74493.250.9594.2393.760.95
2186130-18613092.01892.51
3190993-19099394.42294.94
4187061-18706192.47892.98
5188615-18861593.24793.74
6189362-18936293.61694.14
45min1189371-18937193.62093.311.0394.2593.961.03
2186952-18695292.42593.05
3191673-19167394.75895.42
4186304-18630492.10492.75
5188704-18870493.29193.93
6189488-18948893.67894.34
60min1190222-19022294.04193.330.8594.8194.120.85
2187410-18741092.65193.42
3190809-19080994.33195.14
4186653-18665392.27793.06
5188839-18883993.35794.13
6188815-18881593.34694.15
120min1196997-19699797.39196.550.7598.3097.470.75
2194157-19415795.98696.89
3196761-19676197.27498.22
4193218-19321895.52296.44
5195236-19523696.52097.43
6195380-19538096.59197.54
180min1196745-19674597.26696.170.9798.3297.240.96
2192843-19284395.33796.39
3196741-19674197.26498.36
4192610-19261095.22296.28
5194708-19470896.25997.32
6193478-19347895.65196.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1196327-19632797.05996.000.8798.2697.220.86
2193056-19305695.44296.64
3195617-19561796.70897.95
4191722-19172294.78395.99
5194100-19410095.95897.16
6194344-19434496.07997.31
360min1195012-19501296.40995.361.0097.7596.711.00
2190935-19093594.39495.73
3194952-19495296.38097.76
4190453-19045394.15595.50
5192970-19297095.40096.75
6192961-19296195.39596.77
480min1194095-19409595.95694.840.9697.4496.340.95
2190502-19050294.18095.66
3193938-19393895.87897.41
4189576-18957693.72295.21
5191491-19149194.66896.16
6191384-19138494.61696.14
600min1193240-19324095.53394.241.0597.1795.881.04
2189804-18980493.83495.45
3192344-19234495.09096.76
4187758-18775892.82394.45
5191001-19100194.42696.06
6189642-18964293.75495.42
720min1191472-19147294.65993.621.0196.4395.401.00
2187884-18788492.88594.65
3191591-19159194.71896.53
4187195-18719592.54594.31
5189897-18989793.88095.66
6188143-18814393.01394.82
极限1191325-19132594.58694.682.7496.5096.602.68
2187269-18726992.58194.48
3189587-18958793.72795.68
4201878-20187899.804101.71
5189695-18969593.78195.70
6189280-18928093.57595.52
达格列净二甲双胍缓释片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号100664-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数10
标示量(mg)1000供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.991067481106882610652031068555107007310680280.18
29.961070467107047310704700.01
单位质量响应值RSD%判断
106909.71107476.910.38数据可信
供试品溶液-25041502批-二甲双胍-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132768-327683.0573.368.873.063.368.79
236463-364633.4023.40
332669-326693.0483.05
441318-413183.8553.85
536860-368603.4393.44
635818-358183.3413.34
10min187136-871368.1299.0810.438.139.0810.42
294238-942388.7918.80
393262-932628.7008.70
492527-925278.6328.64
5116071-11607110.82810.83
6100610-1006109.3869.39
15min1136001-13600112.68813.315.0312.7013.335.04
2140896-14089613.14413.16
3141991-14199113.24613.26
4139737-13973713.03613.05
5140911-14091113.14613.17
6156703-15670314.61914.64
20min1176051-17605116.42417.174.5816.4617.214.58
2179145-17914516.71216.75
3195627-19562718.25018.29
4176615-17661516.47616.51
5184141-18414117.17917.22
6192828-19282817.98918.03
30min1238173-23817322.21922.701.9122.2822.771.91
2242355-24235522.60922.67
3242839-24283922.65422.72
4240994-24099422.48222.55
5243892-24389222.75322.82
6251921-25192123.50223.57
45min1312303-31230329.13529.611.9229.2329.711.93
2316913-31691329.56529.66
3319475-31947529.80429.90
4308894-30889428.81728.91
5321248-32124829.96930.07
6325572-32557230.37330.48
60min1374935-37493534.97835.161.5335.1235.301.53
2378693-37869335.32835.47
3376321-37632135.10735.25
4367430-36743034.27834.42
5378891-37889135.34735.49
6384971-38497135.91436.06
120min1575699-57569953.70753.231.4853.9053.431.47
2575602-57560253.69853.89
3564613-56461352.67352.87
4556911-55691151.95452.15
5571245-57124553.29153.49
6579424-57942454.05454.26
180min1694062-69406264.74964.850.9065.0265.130.90
2698694-69869465.18165.46
3690391-69039164.40764.68
4686120-68612064.00864.28
5698364-69836465.15065.43
6703198-70319865.60165.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
240min1793398-79339874.01673.841.2374.3874.211.23
2801173-80117374.74175.11
3784382-78438273.17573.55
4775612-77561272.35772.72
5795942-79594274.25374.63
6798515-79851574.49474.88
360min1930225-93022586.78186.270.8687.2686.760.86
2931322-93132286.88387.37
3919600-91960085.79086.27
4911094-91109484.99685.47
5927448-92744886.52287.01
6929079-92907986.67487.17
480min11020335-102033595.18794.400.8595.8095.010.86
21019248-101924895.08695.70
31004652-100465293.72494.33
4998531-99853193.15393.75
51013990-101399094.59595.21
61014674-101467494.65995.28
600min11070702-107070299.88699.100.75100.6499.860.75
21066239-106623999.469100.23
31058711-105871198.76799.52
41048590-104859097.82398.56
51067427-106742799.580100.34
61062160-106216099.08999.85
720min11092348-1092348101.905101.410.61102.81102.310.61
21091731-1091731101.848102.75
31086389-1086389101.349102.25
41074989-1074989100.286101.17
51091278-1091278101.805102.71
61085550-1085550101.271102.19
极限11095058-1095058102.158101.540.60103.21102.600.60
21090206-1090206101.705102.77
31081955-1081955100.936101.99
41079482-1079482100.705101.74
51094728-1094728102.127103.19
61089130-1089130101.605102.67
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